We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Patient-Centered Care and Asian Americans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02139722
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : July 21, 2020
San Francisco Hep B Free Campaign
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:

Liver cancer and hepatitis B are health disparities for Asian Americans, and hepatitis C is a rising problem. Little is known about how to improve the quality of health care Asian Americans receive for viral hepatitis. Technology, specifically mobile applications, can provide a flexible and efficient way to address these challenges. This project seeks to develop, implement, and test an intervention to increase hepatitis B and C screening for Asian Americans in 2 healthcare systems in San Francisco.

The research team will develop, implement, and evaluate the efficacy of an interactive, patient- centered mobile app for use on a tablet computer to increase hepatitis B and C screening among unscreened Asian Americans age 18 and older. The team will use their experience in health promotion to develop the intervention by working with patients, community leaders and advocates, clinical staff, healthcare providers, and healthcare system administrators from a county safety net system and an academic primary care practice in the San Francisco Bay Area. The mobile application will include video clips with a physician (Video Doctor) addressing patient concerns regarding hepatitis B and C screening in the patient's preferred language, English, Chinese, or Vietnamese. A patient who has not been screened for hepatitis B will answer questions about his or her characteristics and preferences using the mobile application. The mobile application will then show 30-60 seconds video clips with messages that address the patient's responses related to hepatitis B screening and that are delivered by an actor playing a physician. Those who are born between 1945 and 1965 also receive messages about hepatitis C screening. At the end, the tablet computer will generate a provider alert to let the treating provider know what the patient's preferences are regarding testing for viral hepatitis.

Once developed, the intervention will then be used in combination with a physician panel notification and tested against physician panel notification only in a randomized controlled trial to see which approach is better in increasing the rate of hepatitis B and C screening. The team will also work with the 2 healthcare system to ensure that the interventions will be practical and easily adopted once the study is over. The findings of this project will greatly expand understanding about how to use technology- based interventions to improve quality of healthcare in diverse patient populations.

Condition or disease Intervention/treatment Phase
Hepatitis B Hepatitis C Liver Disease Behavioral: Video Doctor, PA + PPN Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 431 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: A Patient-Centered Intervention to Increase Screening of Hepatitis B and C Among Asian Americans
Actual Study Start Date : January 2, 2014
Actual Primary Completion Date : May 28, 2017
Actual Study Completion Date : July 30, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Provider Panel Notification (PPN) Alone
The comparison procedures consist of a panel notification given to providers and an audio-visual presentation on diet and exercise given to patients.
Experimental: Video Doctor, PA + PPN
Video Doctor (VD) and Provider Alert (PA) intervention combined with Provider Panel Notification (PPN)
Behavioral: Video Doctor, PA + PPN
The intervention consists of a Video Doctor and Provider Alert. For the Video Doctor, we will develop a series of 30-60 seconds video clips, a branching algorithm, and a mobile application linking the baseline survey to the clips. The Provider Alert is a point-of-care reminder printout generated by the mobile application to facilitate patient-provider communication. The intervention integrates guidelines, literature, guidance from the Systems Model, our prior work, and input from patients and providers.

Primary Outcome Measures :
  1. EHR-documented hepatitis B surface antigen (HBsAg) test [ Time Frame: 3 months ]
    The main outcome measure is an EHR-documented hepatitis B surface antigen (HBsAg) test at 3 months post-intervention. We chose screening for hepatitis B because, among adults, particularly immigrants or descendants of immigrants, it is the most important first step in the control of viral hepatitis B and lack of screening remains a significant problem. While many young adult Asian Americans born in the U.S. or who immigrated at a young age may have been vaccinated for hepatitis B as a child or prior to entering college, pre-vaccination testing may not have been done. Given the high rates of infection in their parents and the possibility of vertical transmission, all Asian Americans should be tested for chronic hepatitis B using the HBsAg test. All screening outcomes (test receipt) as well as test ordering by the healthcare providers will be collected from the medical record through the EHRs at 3-month post-intervention.

Secondary Outcome Measures :
  1. Knowledge about hepatitis B virus (HBV) and hepatitis C virus (HCV) [ Time Frame: 3 months ]
    Data sources include the self-administered pre-intervention survey via a tablet computer, and the post-intervention phone survey administered by a research assistant, and EHR. All patient surveys will be done in the patient's preferred language (English, Chinese, or Vietnamese). Pre- and post-intervention survey data of secondary outcomes include: Knowledge (awareness of HBV and HCV, screening test, modes of transmission); Self-efficacy (perceived confidence in initiating conversation and request screening test from providers); Patient-Provider Communication Experiences (asked provider for HBV or HCV test, discussed HBV or HCV test with provider, receipt of provider recommendation to get a HBV or HCV test).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • ages 18+ years
  • identifies as Asian
  • Asian American, Chinese, or Vietnamese
  • speaks English, Chinese (Cantonese), or Vietnamese
  • does not have an electronic health record (EHR)-documented HBV screening test (defined as a hepatitis B surface antigen [HBsAg] test).
  • we select Chinese and Vietnamese because those are the 2 most common languages spoken by limited English-proficient Asian Americans

Exclusion Criteria:

  • dementia or any conditions precluding understanding informed consent or using a touch screen with audio

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139722

Layout table for location information
United States, California
Zuckerberg San Francisco General
San Francisco, California, United States, 94110
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
San Francisco Hep B Free Campaign
Patient-Centered Outcomes Research Institute
Layout table for investigator information
Principal Investigator: Tung T Nguyen, MD University of California, San Francisco
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02139722    
Other Study ID Numbers: AD-11-4615
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
hepatitis B
hepatitis C
Asian Americans
mobile technology
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections